AccessGUDID - DEVICE: N/A (04250105604993)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: 30-10-004-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VBM Medizintechnik GmbH

Primary DI Number: 04250105604993
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 324869601 *Terms of Use

Device Description: Quicktrach II Emergency Cricothyrotomy Set for adult

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Cricothyrotome, single-use	A sterile, hand-held, manual surgical instrument intended to be used to perform a cricothyrotomy (an incision through the skin and cricothyroid) providing airway access within seconds for immediate ventilation of the patient and necessary suction procedures. It is used to open a patient's airway in emergency interventions, e.g., accidental blockage of the upper airway tract, and prior to tracheotomy. It is made of high-grade stainless steel and plastic materials. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Cricothyrotome, single-use

A sterile, hand-held, manual surgical instrument intended to be used to perform a cricothyrotomy (an incision through the skin and cricothyroid) providing airway access within seconds for immediate ventilation of the patient and necessary suction procedures. It is used to open a patient's airway in emergency interventions, e.g., accidental blockage of the upper airway tract, and prior to tracheotomy. It is made of high-grade stainless steel and plastic materials. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
BTO	Tube, Tracheostomy (W/Wo Connector)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K874742	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Keep dry, Keep away from sunlight and heat

Clinically Relevant Size

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Size Type Text
Lumen/Inner Diameter: 4 Millimeter

Device Record Status

Public Device Record Key: 0e1ddb46-6252-400b-9a1a-1dd12cb6de37
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: March 30, 2016